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Data / Medical devices / China / Medical Distribution Industries, Ltd.

Medical Distribution Industries, Ltd.: FDA-registered device maker in Kowloon Hong Kong, China, 4 510(k) clearances

Medical Distribution Industries, Ltd. is registered with the FDA (registration 3012711490) in Kowloon Hong Kong, China. It lists 27 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 24, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3012711490
Address
1102 11F, Siu Ying Commercial Building 151 to 155 Queens Road Central, Kowloon Hong Kong, China, None
Owner or operator
Medical Distribution Industries, Ltd. (10052592)
Roles
Exporter to the US
First device listed
August 23, 2016
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Exporter to the USaccessdata.fda.gov
Bandage, CastITG1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Finger CotLZB1Exporter to the USaccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the USaccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the USaccessdata.fda.gov
ForcepsHTD1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Pad, EyeHMP1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Protector, Skin PressureFMP1Exporter to the USaccessdata.fda.gov
Scissors, Medical, DisposableJOK1Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Thermometer, Clinical Color ChangeFQZ1Exporter to the USaccessdata.fda.gov
Valve, Non-RebreathingCBP2Exporter to the USaccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 24, 2022K202903Surgical Face MaskFXXSubstantially EquivalentRizhao Sanqi Medical & Health Articles Co., Ltd.accessdata.fda.gov
July 30, 2021K210691Disposable Nitrile Medical Examination GloveLZASubstantially EquivalentJiangsu Cureguard Glove Co., Ltd.accessdata.fda.gov
November 17, 2017K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)CBPSubstantially EquivalentXiamen Compower Medical Tech. Co., Ltd.accessdata.fda.gov
February 22, 2007K070076POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)LYZSubstantially EquivalentJiangsu Cureguard Glove Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated March 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.